Japan Alteplase Clinical Trial (J-ACT): Efficacy and Safety Study of Tissue Plasminogen Activator (Alteplase) for Ischemic Stroke

NCT ID: NCT00147316

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2003-09-30

Brief Summary

Based on previous studies comparing Duteplase[a recombinant tissue plasminogen activator (rt-PA) very similar to alteplase] doses, we performed a clinical trial with 0.6mg/kg, which is lower than the internationally approved dosage of 0.9mg/kg, aiming to assess the efficacy and safety of alteplase for the Japanese.

Detailed Description

Based on previous studies comparing Duteplase ( an rt-PA very similar to alteplase) doses, we performed a clinical trial with 0.6mg/kg, which is lower than the internationally approved dosage of 0.9mg/kg, aiming to assess the efficacy and safety of alteplase for the Japanese.

The primary endpoints were the rate of patients with mRS score of 0-1 at 3 months and the incidence of sICH within 36 hours. Thresholds for these endpoints were determined by calculating 90% confidence intervals of weighted averages derived from published reports. The protocol was defined according to the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA stroke study with slight modifications.

Conditions

Cerebral Infarction; Brain Ischemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alteplase

0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour

Group Type: EXPERIMENTAL

Alteplase

Intervention Type: DRUG

0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour

Interventions

Alteplase

0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Patients with acute ischemic stroke within 3 hours of onset, with a clearly defined time of onset

Exclusion Criteria

1. patients with rapidly improving neurological symptoms or with minor neurological deficit (National Institutes of Health Stroke Scale (NIHSS) score of ≤4) prior to the start of treatment

2. Computed Tomography (CT) evidence of non-minor early ischemic signs (minor early ischemic sign was defined as the involvement of one-third or less of the middle cerebral artery area)

3. CT evidence of cerebral hemorrhage or subarachnoid hemorrhage

4. symptoms suggestive of subarachnoid hemorrhage

5. lactation, pregnancy or suggestive pregnancy; menstruation

6. platelet count below 100,000/mm3

7. heparin administration within 48 hours preceding stroke onset with an elevated activated partial thromboplastin time (APTT); current use of oral anticoagulants with an International Normalized Ratio (INR) of ≥1.7; use of drugs not allowed to be administered concomitantly with alteplase (other thrombolytic agents, ozagrel sodium, argatroban and edaravone) prior to the study treatment

8. major surgery or serious trauma within the preceding 14 days; serious head or spinal cord trauma within the preceding 3 months

9. a history of gastrointestinal or urinary tract hemorrhage within the previous 21 days

10. arterial puncture at a noncompressible site within the preceding 7 days

11. a history of stroke within the preceding 3 months; a history of intracranial hemorrhage or increased risk of intracranial hemorrhage because of cerebral aneurysm, arteriovenous malformation, neoplasm, etc.

12. concurrent severe hepatic or renal dysfunction

13. malignant tumor under treatment

14. a systolic blood pressure of >185 mmHg or diastolic blood pressure of >110 mmHg

15. a need for aggressive treatment to reduce blood pressure to below these limits(14))

16. blood glucose levels of <50 mg/dL or >400 mg/dL

17. acute myocardial infarction(AMI) or endocarditis after AMI

18. concurrent infectious endocarditis, moya-moya disease (Willis circle occlusion syndrome), aortic dissection, neck trauma, etc.; strong suspicion of ischemic cerebrovascular disorder caused by non-thrombotic occlusion or any other hemodynamic condition

19. seizure at the onset of stroke

20. coma (a Japan Coma Scale score of ≥100)

21. an mRS score of ≥2 before stroke onset

22. a history of hypersensitivity to protein preparations

23. difficulty in monitoring for 3 months

24. less than 3 months since any other clinical trial

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Hakko Kogyo Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Principal Investigators

Takenori Yamaguchi, MD

Role: STUDY_CHAIR

National Cerebral and Cardiovascular Center, Japan

Locations

National Cardiovascular Center

Suita, Osaka, Japan

Countries

Japan

References

Yamaguchi T, Mori E, Minematsu K, Nakagawara J, Hashi K, Saito I, Shinohara Y; Japan Alteplase Clinical Trial (J-ACT) Group. Alteplase at 0.6 mg/kg for acute ischemic stroke within 3 hours of onset: Japan Alteplase Clinical Trial (J-ACT). Stroke. 2006 Jul;37(7):1810-5. doi: 10.1161/01.STR.0000227191.01792.e3. Epub 2006 Jun 8.

Reference Type: RESULT

PMID: 16763187 (View on PubMed)

Hirano T, Sasaki M, Tomura N, Ito Y, Kobayashi S; Japan Alteplase Clinical Trial Group. Low Alberta stroke program early computed tomography score within 3 hours of onset predicts subsequent symptomatic intracranial hemorrhage in patients treated with 0.6 mg/kg Alteplase. J Stroke Cerebrovasc Dis. 2012 Nov;21(8):898-902. doi: 10.1016/j.jstrokecerebrovasdis.2011.05.018. Epub 2011 Jul 7.

Reference Type: DERIVED

PMID: 21737309 (View on PubMed)

Other Identifiers

527-0110

Identifier Type: -

Identifier Source: org_study_id